Compliance with new regulations, the industry's association, was needed. manufacturers's members were critical in establishing collaborative relationships. manufacturers discontinued company's access to databases and committee meetings and considered denying membership due to prior opposition to current regulations.
Met with manufacturers executives in Washington, D.C. with company's representatives including the EVP and Chief Marketing Officer, EVP and President of physician business, and the VP and Chief Compliance Officer. CCO was invited to join manufacturers's government public policy committee; utilized manufacturers resources to reestablish collaborative relations with competitors.
Company protected $289 million in annual drug sales and projected growth targets.

Legislation was introduced to require drug distributors to obtain and maintain chain of custody records for drugs not purchased directly from manufacturer. Company would be at competitive disadvantage if bill passed. Company purchased from both drug and non-drug manufacturers that were not reflective of competition.
Executive management opposed view. Recruited influential local lobbyist and attorney and arranged meeting with Governor. Met with decision makers at FDA and FTC. As a contingency, moved 85% of distributor drug purchases to drug manufacturers. IT and Operations were collaborated with to develop and launch compliance program.
Positioned company to comply with new regulations and protect $289 million in sales.

Statutory incentive payments were offered by the County and the state of Florida to companies located in certain geographic locations for increasing number of resources. Incentive payments increased with higher wages. Company HQ's employee growth was historically 20% annually but was not located in designated location. State required commitment for growth and targeted wages and added penalties for non-compliance.
Determined that headquarters could be annexed into geographical location and made presentations to county supervisors for annex. Duval County approved annex. Company estimated increased growth and average wages; grant was obtained for $4,000 for each new employee during three years.
Company received $2 million in grant payments for meeting growth and wage commitments.

By leveraging business knowledge and relationships with industry groups and government personnel, income opportunities were recognized that related to bad debt on vehicle loans. Senior management at bank was hesitant to approve, questioning clarity in law.
Collaborated with Jacksonville attorney and partnered with a manager in the tax department to verify real opportunities; obtained information from IT to quantify the potential. Created proposals and presented to senior management.
Received $12 million in cash refunds and secured approval to use existing resources to quantify and apply for refunds.

Physician division's CMO proposed customer membership club, based on strategic growth targets, to enable participation in exclusive promotions. Program needed to be introduced to 1,000 reps at the national sales meeting to be effectively established. Meeting was within four months and key elements in first draft potentially implicated OIG fraud and abuse laws.
Compliance and marketing collaborated with an attorney specializing in defending fraud and abuse cases and revised program. Advantage Club concepts were leveraged to meet sales and growth objectives and fit within OIG's safe harbors.
Advantage Club affected 9% in sales net growth that resulted in $587 million in annual sales of medical disposables.

Customer invoices included incorrect sales tax. Major revenue states were auditing company and assessing correct tax plus penalties and interest. Time-consuming tax research was necessary and coding by IT with correct tax rates for more than 145,000 products across 50 states and 100 local jurisdictions.
Recruited CPA firm to accelerate tax research and collaborated with IT to integrate old operating systems into Tax Decision Maker program to ensure that product sales were taxed properly. Tax collection records were uploaded into reporting modules for more than 150 automated monthly returns.
Correct sales tax invoicing reduced auditing expenses 85% in 10 years and improved customer satisfaction.

VP of Procurement was responsible for increasing buy-side margins as determined by the strategic growth plan. VP of Procurement's inability to locate vendor contracts was negatively affecting negotiation position. No vendor contract master list or central storage system for implemented contracts was in place. Multiple managers acted as counsel but no general counsel was on staff.
Collaborated with VP of Procurement and developed senior director of contracts position, an experienced contract attorney with appropriate technical expertise skill set. Presented attorney position to CEO and secured approval to recruit new attorney.
All buy-side margin targets were met and contract approval process was established. The senior director established a database that provided immediate access to electronic documents and paper originals.

Company's qualification to do business in every state for both divisions was outdated. No historical records were kept and no experienced resources were available. Projected rate of acquisitions meant that status needed to be brought current quickly.
Hired paralegal with experience filing annual reports for corporations; set up document files and scanned state-by-state qualifications.
Current annual report filings were up-to-date and enabled company to avoid legal interruptions with seller's Secretary of State. Two mergers per quarter were completed over three years.

Recruited to resolve $2.5 million unpaid sales tax situation that resulted in closure of California distribution center. Company was prevented from selling to government-run medical facilities. All parties involved wanted top priority and there were 150 jurisdictions that needed to be dealt with.
Analyzed potential resolutions and made quantified assessments per state based on available records and prioritized by revenue sources. Collaborated daily with agents to clear records and pay taxes owed; maintained communication with sales reps.
Negotiated 65% reduction in tax assessments to $875,000 in aggregate and remitted collected sales tax; all penalties were waived based on cooperation.

Company had no documented policies, procedures, or metrics in place despite being in heavily regulated business for 17 years. New CEO's public strategy statement included that company "will conduct business in a legal and ethical manner." Company had no culture of compliance or historical measurement of risk. Training curriculum did not exist.
Assumed responsibilities of defining company's compliance with assistance from attorney specializing in healthcare compliance. Collaborated with attorney and conducted corporate compliance and regulatory risk assessment and prioritized risks. Presented action plan to management and board.
Launched corporate compliance plan and designated as Chief Compliance Officer; established an ethics hotline and functioning board Governance Committee in advance of legislation.

FDA inspectors detained latex glove shipments because number of failed gloves in sample exceeded standards. No employee took ownership of detained shipments and no communication process was in place among key decision makers, including logistics department, regional distribution centers, overseas manufacturer and U.S. Customs.
Used existing strong alliance with FDA attorney in Washington, D.C. to learn procedures and timeline for release; quickly instituted action plan to internal personnel and manufacturer and improved QA. Recruited full-time staff to manage paperwork and processes.
Protected $146.4 million in private-label sales and avoided business interruption to large customers. Enabled five-year strategic growth and eliminated further FDA-detained shipments.